parallel randomized trial

REMODEL

Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease

Chronic kidney disease with diabetes Type 2 diabetes (adults)NCT04865770S000395

Design

Randomized: 106
Start year: 2021
Treatment: 52 weeks, follow-up 57 weeks
Countries: multinational (28 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: T2D with HbA1c 9.0 percent or less; eGFR 30 to 75; UACR 20 to under 5000 mg/g

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: randomized
Missing data: multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg once weekly	standard of care with RAS inhibitor; SGLT2 inhibitors in 39.6 percent; lifestyle: not reported	71	71	57
A2	Placebo Placebo	standard of care with RAS inhibitor; SGLT2 inhibitors in 39.6 percent; lifestyle: not reported	35	35	34

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	65.4	65.1
age	sd (years)	9.2	11.3
asian	n	11	4
asian	percent	15.5	11.4
black	n	5	5
black	percent	7.0	14.3
bmi	mean (kg/m2)	30.8	30.8
bmi	sd (kg/m2)	5.7	5.7
diabetes duration	mean (years)	14.2	15.7
diabetes duration	sd (years)	7.9	8.9
egfr	mean (mL/min/1.73 m2)	50.4	52.5
egfr	sd (mL/min/1.73 m2)	10.2	10.9
established cvd: heart failure	n	4	2
established cvd: heart failure	percent	5.6	5.7
established cvd: prior mi or stroke	n	7	2
established cvd: prior mi or stroke	percent	9.9	5.7
female	n	16	9
female	percent	22.5	25.7
hba1c	mean (percent)	7.0	7.1
hba1c	sd (percent)	0.9	0.9
hispanic	n	5	3
hispanic	percent	7.0	8.6
insulin use	n	31	11
insulin use	percent	43.7	31.4
other albuminuria category: A3	n	25	18
other albuminuria category: A3	percent	35.2	51.4
other race not reported	n	6	4
other race other	n	6	0
sbp	mean (mmHg)	133	138
sbp	sd (mmHg)	15	21
sglt2i use	n	28	14
sglt2i use	percent	39.4	40.0
uacr	median (mg/g)	156.0	399.3
uacr	q1 (mg/g)	55.3	69.3
uacr	q3 (mg/g)	464.2	1240
weight	mean (kg)	89.2	90.5
weight	sd (kg)	17.5	21.9
white	n	43	22
white	percent	60.6	62.9

Analyses this trial contributes to

Results

42 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (1 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1 vs A2	md	-0.88 percent		-1.27 to -0.50		hypothetical; randomized; R0007381:Results

Body weight change in kilograms (diabetes) (1 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1 vs A2	md	-4.45 kg		-6.72 to -2.18		hypothetical; randomized; R0007381:Results

Level 2 or 3 hypoglycemia (participants) (2 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 71	not stated; randomized; R0007381:Extended Data Table 5
	A2	events				0 / 35	not stated; randomized; R0007381:Extended Data Table 5

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Detail
52	A1	change	-2.0 mmHg	1.79		hypothetical; randomized; R0007381:Extended Data Table 2
52	A1 vs A2	md	-4.0 mmHg		-9.7 to 1.6	hypothetical; randomized; R0007381:Extended Data Table 2
52	A2	change	2.1 mmHg	2.27		hypothetical; randomized; R0007381:Extended Data Table 2

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 71	not stated; randomized; acute kidney injury; registry:adverse_events
	A2	events				0 / 35	not stated; randomized; acute kidney injury; registry:adverse_events

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	1 / 71	not stated; randomized; R0007381:Figure 1
A1	events	2 / 71	not stated; randomized; registry:adverse_events
A2	events	1 / 35	not stated; randomized; R0007381:Figure 1
A2	events	1 / 35	not stated; randomized; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 71	not stated; randomized; R0007381:Extended Data Table 5
	A2	events				5 / 35	not stated; randomized; R0007381:Extended Data Table 5

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 71	not stated; randomized; R0007381:Extended Data Table 5
	A2	events				1 / 35	not stated; randomized; R0007381:Extended Data Table 5

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 71	not stated; randomized; nausea; registry:adverse_events
	A2	events				2 / 35	not stated; randomized; nausea; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 71	not stated; randomized; diarrhoea; registry:adverse_events
	A2	events				4 / 35	not stated; randomized; diarrhoea; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 71	not stated; randomized; R0007381:Extended Data Table 5
	A2	events				0 / 35	not stated; randomized; R0007381:Extended Data Table 5

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 71	not stated; randomized; R0007381:Extended Data Table 5
	A2	events				0 / 35	not stated; randomized; R0007381:Extended Data Table 5

Diabetic retinopathy complications (4 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	0 / 71	not stated; randomized; R0007381:Extended Data Table 5
A1	events	4 / 71	not stated; randomized; diabetic retinopathy; registry:adverse_events
A2	events	0 / 35	not stated; randomized; R0007381:Extended Data Table 5
A2	events	2 / 35	not stated; randomized; diabetic retinopathy; registry:adverse_events

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 71	not stated; randomized; suicidal ideation; registry:adverse_events
A1	events	1 / 71	not stated; randomized; suicide attempt; registry:adverse_events
A2	events	0 / 35	not stated; randomized; suicidal ideation; registry:adverse_events
A2	events	0 / 35	not stated; randomized; suicide attempt; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 71	not stated; randomized; pancreatic carcinoma; registry:adverse_events
	A2	events				0 / 35	not stated; randomized; pancreatic carcinoma; registry:adverse_events

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 71	not stated; randomized; R0007381:Extended Data Table 5
	A2	events				0 / 35	not stated; randomized; R0007381:Extended Data Table 5

eGFR total slope (5 lines; O51)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	-0.1 mL/min/1.73 m2	1.09		71	hypothetical; randomized; R0007381:Extended Data Table 2
52	A1 vs A2	md	3.4 mL/min/1.73 m2		-0.2 to 6.9		hypothetical; randomized; R0007381:Extended Data Table 2
52	A1 vs A2	md	2.9 mL/min/1.73 m2		-0.2 to 6.1		hypothetical; randomized; R0007381:Extended Data Table 2
52	A1 vs A2	md	2.3 mL/min/1.73 m2		-0.4 to 5.0		hypothetical; randomized; R0007381:Extended Data Table 2
52	A2	change	-3.4 mL/min/1.73 m2	1.43		35	hypothetical; randomized; R0007381:Extended Data Table 2